Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis

• Conditions: Relapse; Multiple Sclerosis
• Interventions: Diagnostic Test: Blood samples and processing

• Registration Number: NCT04380220
• Lead Sponsor: Regina Elena Cancer Institute

Brief Summary

This is a multi-center, prospective, controlled study. MS patients (1° group: 30 patients in relapse; 2° group: 30 patients in remission) and age/sex-matched healthy controls (3° group: 30 subjects) will be enrolled in the study. Patients' disability level will be evaluated by EDSS and MSFC.

Patients and controls will be tested for either coagulation/complement (C3, C4, C4a, C9, fibrinogen, factor VIII and X, D-dimer, protein C, protein S, antithrombin, factor II, aPTT, von-Willebrand factor), soluble markers of endothelial damage (thrombomodulin, Endothelial Protein C Receptor), antiphospholipid antibodies, lupus anticoagulant, complete blood count, viral serological assays or microRNA microarray.

Patients will undergo dynamic susceptibility contrast-enhanced MRI using a 3.0-T scanner to evaluate CBF, CBV, MTT, lesion number and volume.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-07
• Study First Submitted: 2020-04-30
• Status Verified: 2020-05
• Study First Submitted QC: 2020-05-05
• Study First Posted: 2020-05-08
• Last Update Submitted: 2020-05-19
• Last Update Posted: 2020-05-21
• Primary Completion: 2020-08-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• patients diagnosed with relapsing-remitting multiple sclerosis, untreated or treated with only immunomodulatory therapy, in relapse o in remission

Exclusion Criteria

• pregnant, with any neoplastic, hematologic, thyroid, metabolic, thrombotic or autoimmune disease, drug or alcohol addicted, treated with immunosuppressive drugs, steroids o any medication interfering with coagulation.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	Blood samples and processing	Age- and sex-matched healthy control subjects.
Relapsing MS patients	Blood samples and processing	Patients diagnosed with relapsing-remitting multiple sclerosis and in relapse, untreated or treated with only immunomodulatory therapy.
Remitting MS patients	Blood samples and processing	Patients diagnosed with relapsing-remitting multiple sclerosis and in remission, untreated or treated with only immunomodulatory therapy.

Primary Outcome Measures

Name	Time	Method
plasma concentration of coagulation factor	through study completion, an average of 1 year	complement (mg/dl)

Secondary Outcome Measures

Name	Time	Method
Brain MRI hemodynamic changes at DSC 3.0-T MRI	through study completion, an average of 1 year	mean transit time

Trial Locations

Locations (3)

IRCCS Regina Elena National Cancer Institute; 🇮🇹 Rome, Italy

Icahn School of Medicine at Mount Sinai; 🇺🇸 New York, New York, United States

University of Rome Sapienza; 🇮🇹 Rome, Italy